Midterm Outcomes of Multicenter Castor Single-Branch Stent Graft Use in the Treatment of Thoracic Aortic Diseases.

PURPOSE: The aim of this study was to evaluate the midterm efficacy and safety of a single-branch Castor stent graft in the treatment of thoracic aortic disease. MATERIALS AND METHODS: Clinical data of 106 patients with thoracic aortic disease treated with Castor single-branch stent graft at 3 centers were collected between May 2018 and June 2023. The indicators included technical success, stent-related complication, reintervention, retrograde dissection, endoleak, distal stent graft-induced entry (dSINE), branch patency, and mortality. The outcomes of the Castor stent graft for multibranch reconstruction above the arch was also analyzed. RESULTS: The technical success was 98.1% (104/106), while the surgical success was 93.4% (99/106). The reintervention was 2.8% (3/106), consisting of a case of retrograde type A dissection, an endoleak, and a dSINE. The retrograde dissection was 1.9% (2/106), while type I endoleak was 1.9% (2/106). The new dSINE was 2.8% (3/106), and the branch patency rate was 100%. The mortality was 1.9% (2/106). The mean follow-up time was 29.1±17.7 months. The 2-year post-surgery cumulative survival rate was 91.0%±3.1%, while the cumulative branch patency rate was 96.2%±2.2%. In addition, the cumulative freedom from stent-related reintervention rate was 93.2%±2.8%. A comparison showed no significant difference in the stent-related complication, branch patency, endoleak, reintervention, and mortality when the proximal end of the Castor stent graft was anchored to zones 1 or 2 of the aorta. CONCLUSION: Castor single-branch stent graft showed favorable early and midterm outcomes in the treatment of thoracic aortic disease. In addition, it was feasible to combine Castor stent graft with other advanced techniques for multibranch aortic arch reconstruction. CLINICAL IMPACT: The Castor single-branch stent graft was approval by the Chinese Food and Drug Administration in 2017. However, there were few studies on the mid-term outcomes for thoracic aortic disease after launching, which mainly focused on small single-center retrospective study. In the study, we assessed the mid-term outcomes of Castor stent graft through multi-center cases, Castor stent graft combined with other advanced techniques (such as fenestration and hybrid) for multi-branch reconstruction of aortic arch were also conducted. We found Castor single-branch stent graft showed favorable early and mid-term outcomes in the treatment of thoracic aortic disease. Additionally, it was feasible to combine Castor stent graft with other advanced technique for multi-branch aortic arch reconstruction. As an off-the-shelf branched stent graft with a wide range of models, it could be also used in most emergent situation. The Castor stent graft was expected to become more widely used in the future.

Mid-term Outcomes of Endovascular and Hybrid Procedures to Treat Complex Aortic Arch Pathologies.

PURPOSE: To compare the mid-term outcomes of endovascular and hybrid procedures in treating aortic arch pathologies with an unfavorable proximal landing zone, and analyze the different indications of the 2 methods. METHODS: We collected the clinical data from 59 patients with complex aortic arch pathologies who underwent endovascular or hybrid surgery from March 2018 to April 2020 at a single center. Among the patients, 45 were treated by branched or fenestrated surgery and 14 by hybrid surgery. The clinical data of preoperative, perioperative, and postoperative results were retrospectively analyzed and compared. The main study indexes were the branch patency rate and endoleakage rate during the follow-up period. The secondary study indexes included the operation success rate, operative time, hospital expenses, complication incidence, freedom from reintervention rate, mortality, etc. RESULTS: The operation success rate of all the groups was 100%. The hospital expenses of the hybrid group were lower than those of the endovascular group (p<0.05). The operative time of the hybrid group was longer than that of the endovascular group (p<0.05). The incidence of anatomic variants in the hybrid group was 28.6%, which was significantly higher than that in the endovascular group (2.2%, p=0.011). However, there were no significant differences in operative bleeding, ventilator use duration, and treatment time in intensive care units between the 2 groups (p>0.05). Follow-up was conducted for a period of 12 to 34 months. Four patients of the hybrid group experienced numbness of the upper limb (28.57%); the proportion was higher than the endovascular group (0%, p=0.002). There were no significant differences in the occurrence of endoleaks, retrograde aortic dissection, target lesion, secondary operation, branch patency rate, paraplegia, cerebral apoplexy, renal failure, or other complications in either group (p>0.05). The mortality of the endovascular group was 6.67% (3/45). Overall cumulative survival at 1 year was 100% in the hybrid group and 93.3% in the endovascular group. There was no statistical difference in the increase of the true lumen between the 2 groups for vascular remodeling (p>0.05). CONCLUSION: The hybrid surgery costs less and proves more suitable for treating variants of the aortic arch. The endovascular treatment still has limitations due to anatomical conditions.

Fibrin Glue Sac Filling for Preventing Type II Endoleak, Short-Term Outcomes of a Prospective Randomized Controlled Trial.

OBJECTIVE: Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR. METHODS: A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR. RESULTS: A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups. CONCLUSION: Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease. CLINICAL IMPACT: Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.

Systematic Review and Meta-analysis of Short-term and Mid-term Outcomes After Use of t-Branch Off-the-shelf Multibranched Endograft for Elective and Urgent Treatment of Thoracoabdominal Aortic Aneurysms.

OBJECTIVE: To conduct a meta-analysis to assess the safety and efficacy of t-Branch off-the-shelf multibranched endograft for the treatment of thoracoabdominal aortic aneurysm (TAAA). DATA SOURCES: PubMed, Embase, and Web of Science. REVIEW METHODS: Online databases were searched from June 2012 to March 2023. The data were pooled together using a random-effects model of proportions. The outcomes overall included technical success, spinal cord ischemia, target vessel occlusion, type I or III endoleak, reintervention, early mortality (30-day), and mid-term outcomes. Subgroup meta-analyses and meta-regression were performed to explore variation among studies. RESULTS: A total of 15 studies containing 1238 patients were included in the meta-analysis. The overall study quality assessment was found to be moderate to good. The pooled technical success was 97.0% (95% confidence interval [CI]=95.5-98.6, I2=53.01%, 1185/1238 cases, 15 studies). Overall, early mortality was 7.3% (95% CI=4.4-10.1, I2=74.48%, 124/1238 cases, 15 studies). Early spinal cord ischemia was 13.4% (95% CI=9.6-17.2, I2=67.24%, 160/1238 cases, 15 studies), and early type I or III endoleak was 6.0% (95% CI=3.4-8.5, I2=53.71%, 68/1032 cases, 9 studies). Mid-term outcomes showed target vessel occlusion was 4% (95% CI=1.4-6.5, I2=65.18%, 28/528 cases, 10 studies, 5-21.2 months), type I or III endoleak was 4.7% (95% CI=2-7.5, I2=49.74%, 38/512 cases, 10 studies, 5-21.2 months), reintervention was 11.2% (95% CI=8.1-14.3, I2=31.06%, 85/650 cases, 10 studies, 5-21.2 months), and pooled mortality was 13.9% (95% CI=7.2-20.7, I2=76.32%, 84/550 cases, 11 studies, 5-21.2 months). Meta-regression found a significant linear association between higher technical success and earlier publication year (p=0.014) and studies with anatomic inclusion criteria (p=0.037). Urgent patients (p=0.021) and later publication year (p=0.048) were significantly associated with higher early mortality. CONCLUSION: The use of the off-the-shelf t-Branch multibranched endograft for elective or urgent endovascular TAAA repair is associated with high technical success rates and proved to be safe and effective at early and mid-term follow-up. However, the heterogeneity between the included studies is high, and prospective, randomized studies along with future larger studies with long-term follow-up are needed. CLINICAL IMPACT: The Zenith t-Branch (Cook Medical, Bloomington, Ind) was approved as a commercially available device in Europe in June 2012. Although a decade has past, the outcomes of t-Branch have rarely been synthesized at the global level. This meta-analysis included 15 studies containing 1238 patients. The meta-analyses included technical success, major adverse events, reintervention, early mortality, and mid-term outcomes. The outcome was very meaningful and representative for the use of t-Branch. It is helpful for endovascular surgeons to make decisions on the treatment of TAAA patients.

Percutaneous Mechanical Atherothrombectomy Using the Rotarex Device in Acute Ischemic Disease of Lower Limbs: A China Retrospective Multicenter Study on 186 Patients.

BACKGROUND: To evaluate the efficacy and safety of the Rotarex mechanical thrombectomy device in treating acute lower extremity arterial ischemia and to explore the appropriate indication of the Rotarex device. METHODS: A retrospective analysis was performed in 186 patients with acute lower extremity arterial ischemia treated with the Rotarex mechanical thrombectomy device from April 2015 to March 2020 in three vascular surgery centers of Tianjin. As per the comprehensive judgment of the etiology, onset time, imaging of ultrasonography (US) and angiography, and findings during treatment, the patients were divided into the embolization group (69 cases), thrombosis group (primary artery stenosis with thrombosis; 86 cases), and restenosis group (stent restenosis with thrombosis; 31 cases). The primary study outcomes included the success rate of Rotarex mechanical thrombectomy device alone, percutaneous transluminal angioplasty (PTA), stent, catheter-directed thrombolysis (CDT) auxiliary rate, target vessel patency rate, and freedom from clinically driven target lesion revascularization rate (f-CD-TLR). The secondary study outcomes included intraoperative distal arterial embolization, postoperative 30-day bleeding, and deterioration of renal function, amputation, and mortality. RESULTS: The success rate of Rotarex mechanical thrombectomy device alone in the embolization group (44.93%) was significantly higher than that in the thrombosis group (13.95%) and restenosis group (0%) (P < 0.01). The PTA auxiliary rate in the embolization group (26.09%) was significantly lower than that in the thrombosis group (72.09%) and restenosis group (100%) (P < 0.01). The stent implantation rates in the embolization group and restenosis group (11.60% and 33.30%, respectively) were significantly lower than that in the thrombosis group (72.09%) (P < 0.01). There were no significant differences in the CDT auxiliary rate, distal arterial embolization, hemorrhage, renal function deterioration, amputation rate, and mortality among the three groups (P > 0.05). The primary patency at 3 months, 6 months, and 12 months postoperatively was 98.6%, 98.6%, and 84.3% in the embolization group, 96.4%, 89.5%, and 74.9% in the thrombosis group, and 93.2%, 84.7%, and 67.5% in the restenosis group, respectively (P < 0.01). The f-CD-TLR at 12 months postoperatively was 88.9% in the embolization group, which was higher than 77.8% in the thrombosis group and 67.5% in the restenosis group (P < 0.01). CONCLUSIONS: The Rotarex mechanical thrombectomy device is a minimally invasive, safe, and effective treatment option for acute lower extremity arterial ischemia, particularly acute arterial embolization. For acute thrombosis secondary to primary artery stenosis and in-stent restenosis, Rotarex device can effectively reduce the thrombus burden and create favorable conditions for other concurrent interventions.

Midterm outcomes of fenestrated TEVAR using physician-modified endovascular grafts for zone 2.

OBJECTIVES: To summarize the experience and midterm outcomes of physician-modified endovascular grafts for zone 2 thoracic endovascular aortic repair. METHODS: A retrospective analysis was conducted of 51 consecutive patients (mean age 57.6 ± 12.5 years, 39 males) treated with thoracic endovascular aortic repair using physician-modified endovascular grafts for reconstructing the left subclavian artery from November 2015 to December 2019. The primary endpoints during follow-up were the overall mortality, aorta-related mortality, and major complications. The secondary endpoints were reintervention and the patency of the target branches, the demographics and technical details were also described and analyzed. RESULTS: Sixty-three thoracic stent-grafts were deployed in 51 patients and emergency surgery was performed in 10 patients (19.6%). Technical success was 94.1% (48/51). The incidence of perioperative complications was 15.7%, and the 30-day mortality was 0%. At a mean follow-up of 42.0 ± 14.4 months (range, 14-63 months), all the left subclavian arteries remained patent. All-cause mortality was 3.9% (2/51) and not aorta-related deaths. Estimated survival at one and three years was 98.0 ± 1.9% and 96.0 ± 2.8%, respectively. CONCLUSIONS: The physician-modified endovascular grafts is feasible and effective to preserve left subclavian artery in thoracic endovascular aortic repair for aortic arch pathologies with unhealthy proximal landing zone.

Comparative clinical study of short-term outcomes between table fenestrated and chimney endovascular aneurysm repair for hostile neck aneurysms.

OBJECTIVES: Hostile neck abdominal aortic aneurysm (AAA) is challenging for standard endovascular aneurysm repair (EVAR). We sought to compare fenestrated endovascular aneurysm repair (fEVAR) and chimney endovascular aneurysm repair (chEVAR) for hostile neck AAA. METHODS: Patients were identified retrospectively. Hostile neck anatomy was defined as a proximal neck length of <15 mm or angulation >60°. The choice of fEVAR or chEVAR was based on neck anatomy and physician preference. Type I endoleak (T1EL) was the primary outcome. Other outcomes included type III endoleak (T3EL), visceral stent occlusion, renal insufficiency, reintervention, and mortality. RESULTS: A total of 84 patients were included from April 2012 to December 2021. fEVAR and chEVAR patients were 48 and 36 cases, respectively. Both groups showed similar rate of T1EL, T3EL, visceral stent occlusion, renal insufficiency, reintervention, and mortality. However, chEVAR patients had a more tortuous neck (61.1% vs. 16.7%, p < 0.001), while fEVAR patients had a greater neck size (29.5 ± 6.3 mm vs. 24.5 ± 4.8 mm, p < 0.001) and more reconstructing target arteries (2.2 ± 1.1 vs 1.3 ± 0.6, p < 0.001). CONCLUSIONS: fEVAR and chEVAR show similar safe and effective outcomes in well-selected hostile neck. fEVAR might be able to reconstruct multiple visceral arteries, and chEVAR seems justified in patients with poor anatomical suitability for fEVAR.

Distal bare metal stent implantation during thoracic endovascular aortic repair is beneficial to treat complicated type B aortic dissection: A systematic review and meta-analysis.

OBJECTIVE: To explore whether thoracic endovascular aortic repair (TEVAR) plus distal bare metal stent (BMS) implantation leads to favorable clinical outcomes compared with standard TEVAR in treating acute complicated type B aortic dissection. METHODS: Relevant publications were found through a precise search of PubMed, Cochrane Library, and EMBASE. Count data were calculated as the odd ratio (OR)and 95% confidence interval (CI) using the Mantel-Haenszel statistical method, quantitative data were calculated as mean difference and 95% CI using Inverse Variance statistical method. When the data heterogeneity was large, with an I2 > 50%, a random-effects model and sensitivity analysis were performed. The analysis tool we used was the software Revman 5.3 and G*power 3.1. RESULTS: There were 7 publications involving 958 patients who were enrolled ultimately. The incidence of unplanned secondary intervention and postoperative adverse events in the TEVAR + BMS were lower than standard TEVAR (OR, 0.42, (95% CI, 0.23 to 0.75); OR, 0.57, (95% CI, 0.37 to 0.90)), and the pooled number needed to treat was 15 for unplanned secondary intervention and 15 for postoperative adverse events. There were no significant difference in the aortic-related or all-cause 30-day mortality (OR, 0.81, (95% CI, 0.25 to 2.61); OR, 0.47, (95% CI, 0.18 to 1.22)), aortic-related, all-cause mortality at least 6 months or incidence of the postoperative endoleak (OR, 0.47, (95% CI, 0.17 to 1.32); OR, 0.42, (95% CI, 0.17 to 1.06); OR, 0.81, (95% CI, 0.32 to 2.05)). CONCLUSION: There is no significant outcome difference except for reduced reintervention but this does not seem to adversely affect survival. It is unclear whether this justifies the additional cost of placing it in every complicated type B aortic dissection regardless of anatomy after standard TEVAR alone. Besides, more data are needed to verify the adjunctive distal bare metal stents' performance at different dissection stages.

Hyperhomocysteinemia may aggravate abdominal aortic aneurysm formation by up-regulating RASSF2.

Abdominal aortic aneurysm (AAA) is a fatal cardiovascular disorder with high mortality and morbidity rates. To date, no drug has shown to significantly alleviate the risk of AAA. Previous studies have indicated that hyperhomocysteinemia (HHcy) significantly increases the incidence of AAA by disrupting endothelial cell homeostasis; however, the potential molecular mechanisms require clarification. Herein, we aimed to integrate transcriptomics analysis and molecular biology experiments to explore the potential molecular targets by which HHcy may increase the incidence of AAA. We integrated two AAA data profiles (GSE57691 and GSE7084) based on previously published microarray ribonucleic acid sequencing (RNAseq) data from the GEO database. Additionally, 500 µM homocysteine-treated human aorta endothelium cells microarray dataset (GSE175748) was downloaded and processed. Subsequently, single-cell RNA-seq profiles of the aortic aneurysms (GSE155468) were downloaded, scaled, and processed for further analysis. The microarray profiles analysis demonstrated that the Ras association domain family member 2 (RASSF2) and interleukin (IL)-1ß are potentially the target genes involved in the HHcy-mediated aggravation of AAA formation. Single-cell RNAseq analysis revealed that RASSF2 might impair endothelial cell function by increasing inflammatory cell infiltration to participate in AAA formation. Finally, we conducted reverse transcription quantitative polymerase chain reaction and immunofluorescence analysis to validate the up-regulated mRNA expression of RASSF2 (p = 0.008) and IL-1ß (p = 0.002) in AAA tissue compared to control tissue. Immunofluorescence staining revealed overexpression of RASSF2 protein in AAA tissue sections compared to control tissue (p = 0.037). Co-localization of RASSF2 and the aortic endothelium cell marker, CD31, was observed in tissue sections, indicating the potential involvement of RASSF2 in aortic endothelial cells. To summarise, our preliminary study revealed that HHcy may worsen AAA formation by up-regulating the expression of RASSF2 and IL-1ß in aortic endothelium cells.

A nomogram risk assessment model to predict the possibility of type II endoleak-related re-intervention after endovascular aneurysm repair (EVAR).

This study aimed to develop and validate a novel nomogram risk assessment model to predict the possibility of type II endoleak (T2EL)-related re-intervention. The data of 455 patients with abdominal aortic aneurysms who underwent elective endovascular aneurysm repair (EVAR) procedures between January 2018 and December 2021 at our single center were retrospectively reviewed. Following the implementation of exclusion criteria, 283 patients were finally included and divided into T2EL-related re-intervention (n = 42) and non-T2EL (n = 241) groups. The overall T2EL-related re-intervention rate for 283 patients was 14.8% (42/283). Using multivariate analysis, significant risk factors for re-intervention included age (OR, 1.172; 95% CI, 1.051-1.307; P = 0.004), smoking (OR, 13.418; 95% CI, 2.362-76.215; P = 0.003), diameter of inferior mesenteric artery (IMA) (OR, 21.380; 95% CI, 3.060-149.390; P = 0.002), and number of patent lumbar arteries (OR, 9.736; 95% CI, 3.175-29.857; P < 0.001). The discrimination ability of this risk-predictive model was reasonable (concordance index [C-index] = 0.921; 95% CI, 0.878-0.964). The Hosmer-Lemeshow goodness of fit test was performed on the model, and the chi-square value was 3.210 (P = 0.920), presenting an excellent agreement between the model-predicted and observed values. The receiver operating characteristic (ROC) curve identified that the risk thresholds of re-intervention were a diameter of > 2.77 mm for the diameter of the inferior mesenteric artery and a proportion of < 45.5% for thrombus volume in the aneurysm sac. This novel nomogram risk assessment model for predicting the possibility of patients' T2EL-related re-interventions after EVAR should be helpful in discriminating high-risk patients. Two novel risk thresholds may imply a higher possibility of T2EL-related re-intervention after EVAR.

Construction of a canine model with acute type B aortic dissection using a self-made pressure-driven flow device.

A reproducible canine aortic dissection (AD) model would be useful for evaluating the performance of novel endovascular treatment devices. Therefore, we attempted to create a reproducible canine model of Stanford type B AD (TBAB) by a surgical method. Computed tomography angiography was performed 2 h after the procedure to determine if a false lumen was present, and follow-up imaging was performed 10 d after the procedure using digital subtraction angiography, intravascular ultrasound (IVUS), and color Doppler flow imaging (CDFI) to confirm stable persistence of the false lumen. The success rate of model construction was 88.8% (16/18). All surviving dogs had distal re-entries (16/16). The number of re-entries in the dogs was 1.50 ± 0.52, and the mean length of the false lumen was 175.37 ± 16.98 mm. IVUS showed the area of the false lumen at the narrowest part of the arterial lumen was 84.88 ± 1.27%. The CDFI showed that the peak systolic velocity in the false lumen (10.89 ± 0.74 cm/s) was significantly slower than that in the true lumen (25.31 ± 1.72 cm/s; P<0.001). Moreover, the direction of blood flow in the true lumen was consistent, whereas that in the false lumen was disordered. We optimized the traditional surgical method to construct a canine model of TBAD to improve the success rate of model construction, and designed a novel device to lengthen the false lumen. The proposed model has wide implications in evaluating the performance of novel endovascular treatment devices and studying the AD-related hemodynamics.

Identification of novel genetic biomarkers and treatment targets for arteriosclerosis-related abdominal aortic aneurysm using bioinformatic tools.

A large number of epidemiological studies have confirmed that arteriosclerosis (AS) is a risk factor for abdominal aortic aneurysm (AAA). However, the relationship between AS and AAA remains controversial. The objective of this work is to better understand the association between the two diseases by identifying the co-differentially expressed genes under both pathological conditions, so as to identify potential genetic biomarkers and treatment targets for atherosclerosis-related aneurysms. Differentially-expressed genes (DEGs) shared by both AS and AAA patients were identified by bioinformatics analyses of Gene Expression Omnibus (GEO) datasets GSE100927 and GSE7084. These DEGs were then subjected to bioinformatic analyses of protein-protein interaction (PPI), Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG). Finally, the identified hub genes were further validated by qRT-PCR in AS (n = 4), AAA (n = 4), and healthy (n = 4) individuals. Differential expression analysis revealed a total of 169 and 37 genes that had increased and decreased expression levels, respectively, in both AS and AAA patients compared with healthy controls. The construction of a PPI network and key modules resulted in the identification of five hub genes (SPI1, TYROBP, TLR2, FCER1G, and MMP9) as candidate diagnostic biomarkers and treatment targets for patients with AS-related AAA. AS and AAA are indeed correlated; SPI1, TYROBP, TLR2, FCER1G and MMP9 genes are potential new genetic biomarkers for AS-related AAA.